Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy

Periodontitis, Adult Clinical Trial

Official title:

Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy: A Randomized, Split-Mouth Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05293301
• Other study ID #: IRB#9587
• Status: Completed
• Phase: N/A
• Start date: August 17, 2018
• Est. completion date: March 5, 2020

Study information

• Verified date: March 2022
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare the clinical outcomes of teeth deep cleaning or scaling and root planing (SRP) using a periodontal endoscope (Perioscopy®) versus traditional SRP using magnifying loupes for up to twelve months, utilizing a split mouth design.

Description:

Twenty-five (25) patients were recruited for the study that exhibited mild to moderate periodontitis. SRP or deep cleaning was rendered by the same experienced hygienist, following random assignment of the left or right half of the mouth to either recieve deep cleaning by using a periodontal endoscope (Perioscopy®) or traditional deep cleaning using magnifying loupes. All the periodontal evaluations were done by the same periodontal resident at baseline, one month, three months, six months, and twelve months after deep cleaning.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older
• in good general health
• given a diagnosis of mild-moderate generalized chronic periodontitis per the 1999 world workshop classification of periodontal diseases and conditions
• required whole mouth SRP
• teeth had a maximum of 6mm probing pocket depth at any site
• at least one molar present in each arch, excluding third molars.

Exclusion Criteria:

• any requirement for antibiotic premedication prior to dental treatment
• uncontrolled hypertension
• uncontrolled diabetes
• subject unwilling to sign the informed consent
• subject needed any antibiotic intervention for unrelated conditions

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Periodontitis, Adult

Intervention

Device:
• Use of Periodontal Endoscope (Perioscopy®) to enhance visualization while performing teeth deep cleaning
Deep cleaning or scaling and root planing (SRP) using a Periodontal Endoscope or Perioscopy® for enhanced visualization, on teeth in one half of the mouth
• Use of traditional loupes to enhance magnification to enhance visualization while performing teeth deep cleaning
Deep cleaning or scaling and root planing (SRP) using tradional loupes for enhanced visualization on teeth, in the other half of the mouth

Locations

Country	Name	City	State
United States	LSU Health New Orleans School of Dentistry (Dept of Periodontics)	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm	Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.	3 months
Primary	Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.	Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.	3 months
Primary	Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.	The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.	3 months
Primary	Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.	Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.	6 months
Primary	Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.	Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.	6 months
Primary	Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.	The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.	6 months
Primary	Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.	Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.	12 months
Primary	Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.	Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.	12 months
Primary	Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.	The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.	12 months
Secondary	Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.	Probing pocket depth (in mm) around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.	3 months
Secondary	Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.	Clinical attachment level (in mm) around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.	3 months
Secondary	Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.	Presence or absence of bleeding on probing around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.	3 months
Secondary	Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.	Probing pocket depth (in mm) around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.	6 months
Secondary	Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.	Clinical attachment level (in mm) around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.	6 months
Secondary	Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.	Presence or absence of bleeding on probing around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.	6 months
Secondary	Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.	Probing pocket depth around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.	12 months
Secondary	Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.	Clinical attachment level (in mm) around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.	12 months
Secondary	Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.	Presence or absence of bleeding on probing around teeth, will be compared between similar sites on different teeth, including; single-rooted vs multi-rooted teeth, maxillary vs mandibular teeth.	12 months